Novel Therapeuticfor Multidrug Resistant TuberculosisAdam Smith 3rd International Forum PHARMA ASI, November 21-23, 2012

Global Burden of MDR Tuberculosis

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14 million TB patients worldwide

About 0,5 million cases of MDR TB

First 5 countries with MDR-TB: India (131 000), China (112 000), the Russian Federation (43 000), South Africa (16 000) and Bangladesh (15 000).

25% of global MDR TB treatment expenses are spent in Russia

Only 22% of MDR TB patients in Russia receive appropriate treatment

Unmet medical needs

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The existing TB-treatment regimens are based on the drugs developed in the 40’s, 50's, early 60's

The existing drugs have poor or no effect on MBT (drug resistance)

The growing incidence of MDR TB worldwide

A number of cases of total drug resistance

The treatment cost of MDR-TB patients is in average 10 times higher than drug-sensitive

SQ109Unique mechanism of action

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Targets MmpL3, a membrane transporter of Tregalose Monomycolate involved in Mycolic Acid donation to the MBT cell wall

Prevents drug efflux of other companion drugs, improving their kill capacity

1,2-diamine related to ethambutol

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SQ109Key advantages

Synergistically improves other drug activity:

8-fold for Rifampicin, Rifapentine (Sanofi), Rifabutin (Pfizer)

4 to 8-fold for TMC207 (J&J Tibotec)

2 to 4-fold for PNU100480 (Pfizer)

8-fold for Clofazimine (generic)

No natural resistance and low resistance generation rate:

≥1000-fold better than other TB drugs:

Resistance generation, 1 in 2x1012 (2 trillion) bacteria

Effective against latent TB infection

No expected drug-drug interaction

2D6 and 2C19 Cytochrome P450

no interaction with 3A45

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SQ109Combination therapy – preclinical data

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Residual CFU M. tuberculosis after 6 wk treatment

Undiluted lung homogenate samples plated on 7H10 agar

INH+RIF+EMB+PZA(standard of care)

INH+RIF+ SQ109 +PZA

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SQ109Development status and strategy

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Proved preclinical safety and efficacy (in vitro and in vivo)

Proved safety in series of early stage clinical trials

80 healthy subjects in 5 phase 1 CT

90 TB subjects in phase 2A EBA study

Ongoing long-term preclinical testing (in vivo)

Ongoing pivotal clinical trial in Russia for MDR TB treatment

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Intellectual Property

Exclusive Licensing

License object: Patent EA № 013965. Expiry: 19.05.2023.Title: Anti tubercular drug: compositions and methods

License territory: RF, Ukraine, Belarus, Kazakhstan, Moldova, Kirgizia, Tajikistan, Turkmenistan, Azerbaijan, Armenia

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Team

Oksana Markova — Chief Executive Officer

Graduated from Smolensk Medical Academy, was engaged in research activities. Since 1997, worked for InnoFarm, went all the way from the centers monitor to clinical project manager. Knows all the aspects of the organization of clinical trials and registration of the finished drug products. Since 2010, as part of Maxwell Biotech Group organized the evaluation of the incoming projects at clinical stage, participated in the planning of clinical studies and the preparation of investment decisions. Since 2011 — CEO of Infectex

Sergey Borisov — Scientific AdvisorDoctor of Medical Science, Professor of TB at Russian Medical

Academy of Postgraduate Education, Deputy Director for science and clinical work at Moscow Research Center for TB control of the Moscow Department of Health.

Main scientific work (300 papers in national and international journals) is devoted to the diagnosis, treatment and follow-up of patients with tuberculosis and other respiratory diseases.

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Infectex Ltd

markova@infectex.ru

+7 (495) 411-69-92

Thank you for your attention